Overview

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Massachusetts General Hospital
Treatments:
Denosumab
Teriparatide
Criteria
Inclusion Criteria:

- women aged 45+

- postmenopausal

- osteoporotic with high risk of fracture

Exclusion Criteria:

- significant previous use of bone health modifying treatments

- known congenital or acquired bone disease other than osteoporosis

- significant renal disease, liver disease, cardiopulmonary disease, or psychiatric
disease

- abnormal calcium or parathyroid hormone level

- serum vitamin D <20 ng/mL or >60ng/mL

- serum alkaline phosphatase above upper normal limit with no explanation

- anemia (hematocrit <32%)

- history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or
gouty arthritis

- history of urolithiasis within the last one year

- excessive alcohol use or substance abuse

- use of oral or parenteral glucocorticoids for more than 14 days within the past 6
months

- extensive dental work involving extraction or dental implant within the past or
upcoming 2 months

- known sensitivity to mammalian cell-derived drug products

- known contraindications to denosumab, teriparatide, or any of their excipients

- known contraindications to tetracycline, demeclocycline, or other antibiotics in this
drug class

- continuous use of tetracycline for >1-month duration within the last 10 years